Automation Alliance Raises Stakes in Infectious Disease Diagnostics Compliance
Genetic Signatures has formed a strategic partnership with Tecan and Repado to develop a fully automated, scalable infectious disease testing platform integrating advanced automation, compliant software, and proprietary assays.
- Strategic partnership formed between Genetic Signatures, Tecan, and Repado
- Development of a fully integrated, sample-to-answer infectious disease testing platform
- Platform combines Tecan’s automation, Repado’s compliant software, and Genetic Signatures’ assay portfolio
- Focus on regulatory compliance with IVDR, FDA, and ISO 13485 standards
- Early access systems planned for select global reference laboratories
A New Era in Infectious Disease Testing
Genetic Signatures, a specialist in molecular diagnostics, has announced a strategic collaboration with Tecan and Repado aimed at revolutionizing infectious disease testing. This partnership seeks to deliver a fully automated, scalable platform that streamlines the diagnostic process from sample collection to result reporting.
The alliance leverages the strengths of each partner, Tecan’s renowned liquid handling automation, Repado’s modular and regulatory-compliant software designed for in vitro diagnostics, and Genetic Signatures’ proprietary infectious disease assays. Together, they aim to create a seamless, integrated solution tailored for syndromic testing laboratories.
Driving Efficiency and Compliance
One of the key benefits of this new platform is the automation of complex molecular workflows, which promises to reduce hands-on time and minimize operator errors. The design is aligned with stringent regulatory frameworks, including the European IVDR, FDA requirements, and ISO 13485 standards, ensuring laboratories can maintain compliance while scaling operations.
Such regulatory readiness is critical as laboratories worldwide face increasing demands for rapid, reliable infectious disease diagnostics. The platform’s flexibility allows deployment across various settings, from centralised labs to hospital networks and global distribution partners, broadening its potential impact.
Market Implications and Future Outlook
Currently, the first concept systems are under development, with early access planned for select global reference laboratories and clinical partners. This phased approach allows the partners to refine the technology and validate its performance in real-world settings before wider commercial release.
Additionally, Genetic Signatures is expanding its 3base® technology syndromic infectious disease menu, which will be launched alongside the integrated hardware and software solution. This expansion underscores the company’s commitment to offering comprehensive diagnostic options that meet evolving clinical needs.
Overall, this collaboration marks a significant step forward for Genetic Signatures, positioning it to better serve the growing global demand for efficient, automated infectious disease testing solutions.
Bottom Line?
As development progresses, this partnership could reshape infectious disease diagnostics with scalable, compliant automation.
Questions in the middle?
- What is the timeline for commercial launch and broader market availability?
- How will this platform compare in cost and performance to existing diagnostic solutions?
- What are the plans for expanding the assay menu beyond initial panels?
